Lab capacity could halt EU endocrine disruptor assessments

The pesticide industry has voiced concerns that substance evaluations against the new criteria for identifying endocrine disruptors (EDCs) could grind to a halt because of capacity issues at testing laboratories.

Discussing the issue at the Fresenius International EDC conference in November, stakeholders warned that a large number of active substances will need to be evaluated at the same time.

The criteria became applicable under the biocidal products Regulation (BPR) on 7 June. For pesticides, this was from 10 November.

These dates introduced a 'stop the clock' mechanism for ongoing substance evaluations under the two laws. Assessments will be put on hold until the applicants and evaluating authorities have obtained and assessed the additional data needed to conclude on the EDC criteria.

Under the BPR, approval decisions for more than 30 active substance and product-type combinations are already on hold awaiting assessment. Echa has, however, assured industry that it will only be asked to generate additional data if "absolutely necessary".

And under the plant protection products (PPP) Regulation, 'stop the clock' will apply to any pending application for the renewal of a substance that was submitted before 10 November.

Backlog expected

At the conference in Cologne, several industry stakeholders voiced concerns that hundreds of PPP substances will be held back for testing.

Jean-Pierre Busnardo from Corteva Agriscience – the agricultural division of DowDuPont – said that this, combined with the complexity of testing for endocrine disrupting properties according to the relevant guidance, will cause significant delays.

Performing the relevant testing will typically take six to nine months if contracted out to an independent laboratory, he said. But with most companies lacking the expertise to test against the EDC criteria in-house, "we will all be competing for the laboratories' time and expertise".

While this is not likely to be a problem for performing the simpler in vitro tests, Mr Busnardo expected "serious capacity problems" for completing the in vivo tests.

In addition, the testing is new ground even for experts. Some of the tests "are not necessarily sufficiently validated at this stage" and will be a challenge for the laboratories, he said.

Mr Busnardo also said that a lot of data will need to be generated in the coming years that will rely on lab animals. This, he said, does not fit with highly established EU principles on the subject.

Deadlines

Applicants will also have deadlines to comply with. For pesticides, the European Food Safety Authority (Efsa) will set applicants a deadline for the submission of extra data, which may not exceed 30 months, the European Commission’s head of sector pesticides, Karin Nienstedt said in Cologne.

Once submitted, the evaluating member state will be allowed 60 days to assess the information.

"What happens if I can't deliver on the Efsa specified deadlines?" Mr Busnardo asked. "Will my substance go off the market? The European Commission needs to take [testing] shortages into account. If they're not, a number of substance will miss their deadlines."

When asked whether the Commission is worried about lab capacity issues, Ms Nienstedt said Brussels is "aware that this will mean a lot of additional work for everybody". She added that there could be "pragmatic strategies to reduce the workload and reduce animal testing" for substances that are of low concern.